Effectiveness of the Walking Intervention Walkadoo: A Ran... | NCT02229409

Studies
Effectiveness of the Walking Intervention Walkadoo: A Randomized Controlled Pilot Trial in an Employee Population

NCT02229409

Sponsor

MeYou Health, LLC

Status

Completed

Last Update Posted

Feb 4, 2016Estimated

Enrollment

265Actual

Phase

Not Applicable

Conditions

Healthy

Interventions

Walkadoo

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2016

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 2014

Primary Completion Date

Nov 2014Actual

Completion Date

Nov 2014Actual

First Submitted Date

Aug 28, 2014

First Submission Date that Met QC Criteria

Aug 29, 2014

First Posted Date

Sep 1, 2014Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 3, 2016

Last Update Posted Date

Feb 4, 2016Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

This study evaluates the product Walkadoo to determine whether it effectively increases walking behavior in healthy adults.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

265Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Control	No Intervention	Observation only, no behavioral intervention
Intervention	Experimental	Intervention Walkadoo.	Behavioral: Walkadoo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Walkadoo	Behavioral	Walkadoo is a MeYou Health, LLC product.	Intervention

Measure	Description	Time Frame
Average steps per day		6 weeks

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Adults 18 years or older;
Healthways employees based in Franklin, TN with an email account with the company;
Provide informed consent and complete eligibility questionnaires

Exclusion Criteria:

Current or prior use of the intervention Walkadoo
Presence of a chronic condition that affects walking
Projected inability to access the internet for 4 consecutive days or longer during the study
Non-adherence to device wear during baseline

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Nathan K Cobb, MD	Georgetown University	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
MeYou Health		Boston	Massachusetts	02210	United States

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
26860434	Derived	Poirier J, Bennett WL, Jerome GJ, Shah NG, Lazo M, Yeh HC, Clark JM, Cobb NK. Effectiveness of an Activity Tracker- and Internet-Based Adaptive Walking Program for Adults: A Randomized Controlled Trial. J Med Internet Res. 2016 Feb 9;18(2):e34. doi: 10.2196/jmir.5295.